Constant respiratory failure Ban on codeine cough syrup

BfArM: codeine cough syrup is prohibited for children and adolescents
Cough syrup with codeine for the treatment of children and adolescents may no longer be placed on the market, according to the latest communication from the Federal Institute for Drugs and Medical Devices (BfArM). "Due to the risk of respiratory depression", a European risk assessment procedure had been carried out for "codeine-containing medicines for the treatment of children and adolescents with cough", the result of which was negative, reports the BfARM.
In view of the results of the risk assessment procedure, inter alia, the treatment of children under the age of 12 with codeine-containing anti-cough medicines was prohibited. The "codeine CT 5 mg / 5 ml, may therefore no longer be placed on the market or given away", reports the BfArM. In addition, liquid drugs containing codeine may in future only be dispensed in child-resistant packaging in order to avoid medication errors and misuse, such as overdoses.

Cough syrup with codeine is prohibited for children and adolescents. Picture: photophonie - fotolia

Benefit-risk ratio negatively assessed
According to the BfArM, the reassessment of the risk-benefit ratio for codeine revealed that fatal and life-threatening cases related to codeine occurred in children who were so-called ultrafast metabolizers. In her body, the codeine was converted very quickly into morphine. Due to the high morphine content in the body had serious side effects such as restricted breathing occurred.

Given the lack of rapid tests to check for the existence of a corresponding predisposition, it can not be foreseen how a patient metabolises codeine. The benefit-risk ratio was therefore subsequently stated to be "negative with respect to use in children and adolescents," the BfArM reports. The preparations may no longer be placed on the market, as long as no adaptation of the technical and usage information to the current state of scientific knowledge takes place.

Death related to codeine
In the period from 1978 to 2012, the BfArM stated that "a death was reported for Codeine in childhood". Therefore, a further risk assessment procedure at European level was launched in 2014, which also assesses the benefit-risk profile for the treatment of coughs. Relationship. According to the Federal Institute for Drugs and Medical Devices, the current restrictions are the result of this procedure. (Fp)